Cleared Traditional

K173913 - MEDRAD® Imaging Bulk Package Transfer Set (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173913 · Bayer U.S., LLC · General Hospital
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May 2018
Decision
133d
Days
Class 2
Risk

K173913 is an FDA 510(k) clearance for the MEDRAD® Imaging Bulk Package Transfer Set. Classified as Iodinated Contrast Media Transfer Tubing Set (product code PQH), Class II - Special Controls.

Submitted by Bayer U.S., LLC (Indianaola, US). The FDA issued a Cleared decision on May 4, 2018 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K173913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date May 04, 2018
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 128d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PQH Iodinated Contrast Media Transfer Tubing Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition The Iodinated Contrast Media Transfer Set Is Intended To Transfer Iodinated Contrast Media From Imaging Bulk Package Contrast Media In A Controlled Ambient Environment. The Transfer Set Is Intended To Be Used To Directly Fill Multiple Sterile Single Use Syringes From An Imaging Bulk Package Contrast Media Bulk Package Under Controlled Ambient Filling Conditions Such As A Ct Suite.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.